Medical device software process improvement: A perspective from a medical device company

When manufacturing medical devices there are many constraints that have to be taken into account such as safety, compliance with regulations and traceability. To do this, well-defined processes are used. With this in mind we examine how process improvement is implemented in a medical device company while managing the resultant change. The case study presented in this paper investigates the use of Kotter's Change Model to support the implementation of process improvement in a medical device company. The results of the case study demonstrate that Kotter's change model was an appropriate model to use. The sense of urgency Kotter stipulates was inherent in the company. The team was aware that change was needed. A flaw in Kotter's approach is that there is no recommendation for a pilot project. Having a pilot project worked well for this company as it helped to eliminate stress and anxiety. A further case study is planned in the company to observe how the process is working after implementation of the full project.